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U.S. Department of Health and Human Services

Safety

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Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes: Class 1 Recall-Weak or Open Seals

[Posted 11/23/2010]
 
AUDIENCE:  Hospital Risk Managers, Otolaryngology

ISSUE: These medical products are contained in sterile pouches that have weak or open seals. These products could become or have been contaminated due to compromise in sterility. This can cause serious adverse health consequences and/or death.

BACKGROUND: Date Recall Initiated by firm March 15, 2010.  These products were distributed from February 15, 2010 through March 4, 2010. The use of these products:
Surgical Sealant Dispenser – Instrument for the application of two liquids
Micromedics Nasal Septal Button – Used for nonsurgical closure of an opening in the septum of the nose
Otological Ventilation Tubes – Implants designed to provide ventilation to the middle ear space through the eardrum (tympanic membrane). Used when there is there is a chronic failure of the tube that connects the middle ear to the nose (Eustachian tube) and when the problem does not respond to conventional therapy.

RECOMMENDATION: For specific model and lots numbers please view the Medical Device Recall. Customers are advised to contact their Customer Service to return any affected product for replacement at 1-800-624-5662 or 651-452-1977 ext. 224., Monday- Friday, 7:30am-5pm, Central Time. 
 
[11/23/2010 - Recall Notice - FDA]